Medical device with forward and sideward ablation monitoring ultrasound transducers

ABSTRACT

The invention relates to ultrasound imaging method and apparatus suitable for minimally invasive ultrasound diagnostic devices in cardiac ablation monitoring and in tumor ablation monitoring. The present invention proposes an assembly of forward and side-facing transducers and a system of embedded forward and side-facing transducers in apertures on surfaces of the assembly. This provides control of the acoustic properties of the transducer and improved ablation monitoring when the assembly is incorporated in a medical device.  FIG.  10

CROSS REFERENCE TO RELATED APPLICATIONS

This application a continuation of prior application serial no.16/129,837, filed Sep. 13, 2018, entitled “Medical Device with Forwardand Sideward Ablation Monitoring Ultrasound Transducers”, now U.S. Pat.No. 11,707,260, which is a divisional of prior application serial no.13/885,796, filed Feb. 4, 2014, entitled “Medical Device with UltrasoundTransducers Embedded in Flexible Foil”, now U.S. Pat. No. 10,238,364,which is a national stage entry of PCT/IB11/54330, filed Oct. 3, 2011.These applications claim priority to EP 10191687.2, filed Nov. 18, 2010,which is incorporated by reference herein in its entirety for allpurposes.

FIELD OF THE INVENTION

The invention relates to ultrasound imaging apparatus suitable forminimally invasive ultrasound diagnostic devices. The invention can beused for fabrication of interventional devices used in cardiac ablationmonitoring and in cancer ablation monitoring.

BACKGROUND OF THE INVENTION

Radiofrequency (RF) catheter ablation is an invasive procedure used toremove faulty electrical pathways from patients who are prone to developcardiac arrhythmias such as atrial fibrillation (AF). In AF ablationprocedures, complete electrical isolation of the pulmonary veins istargeted and this is achieved by creating lesion lines with an ablationcatheter.

The majority of the catheter ablation procedures are performed with“single-point ablation catheters”. Lesion lines can be created with suchcatheters by sequential point by point ablation. To achieve completeelectrical isolation of the pulmonary veins lesion lines are createdmeeting the two requirements of being transmural and continuous.

A requirement for RF catheters is a more adequate control. A system thatcan provide a real-time feedback of the lesion development in thetissue, and can provide real-time information about the depth of thelesion with respect to the thickness of the tissue at the treatmentsite, would prevent injury and potential death from overheating in (RF)catheter ablation procedures, while insufficient heating results inrecurrence of arrythmia. It has been shown that high-frequencyultrasound can be used to monitor the progression of the lesion boundaryin M-mode imaging.

Embedding ultrasound transducers in ablation catheters enables real-timefeedback on lesion front progression.

US 7,846,101 discloses an intravascular ultrasound imaging apparatuscomprising a transducer assembly. The assembly includes a flexiblecircuit comprising transducer elements attached to a flexible substrate.However, as the flexible substrate is part of the material stack formingthe assembly, the flexible foil may produce acoustical effect adverse tothe transducer elements performance.

The inventor of the present invention has appreciated that an improvedtransducer assembly is of benefit, and has in consequence devised thepresent invention.

In particular it would be advantageous to realize a transducer assemblyhaving acoustic properties depending only on the transducer elementmaterial. It would also be desirable to enable the user of RF catheterto access real-time feedback of the lesion development in tissue duringRF catheter ablation procedure.

SUMMARY OF THE INVENTION

In general, the invention preferably seeks to mitigate, alleviate oreliminate one or more of the above mentioned disadvantages singly or inany combination. In particular, it may be seen as an object of thepresent invention to provide a method that solves the above mentionedproblems, or other problems, of the prior art.

To better address one or more of these concerns, in a first aspect ofthe invention an ultrasound transducer assembly is presented thatcomprises a flexible foil having openings extending from a top to abottom surface of the flexible foil; one or more piezoelectric elementscontained into the openings and fastened to the internal rim of theopenings; one or more conductive layers deposited on the flexible foiland on the one or more piezoelectric elements.

By placing piezoelectric elements into the openings of the flexiblefoil, the properties of piezoelectric elements are not influenced by thematerial of the flexible foil and therefore desired tuning of theperformance of the transducer assembly can be obtained. As thetransducer assembly comprises one or more piezoelectric elementsembedded into the flexible foil, the flexible foil does not influencethe acoustical performance of the transducer. The inside edge, i.e. theintemal rim of the opening of the flexible foil is fastened to thepiezoelectric element, i.e. the external edge of the piezoelectricelement.

The flexible foil maybe e.g. a Kapton foil, metalized with, e.g. copper,having openings, i.e. holes to contain piezoelectric elements. Thepiezoelectric elements are, e.g. piezoelectric patches.

In some embodiments the flexible foil comprises metallization tracks.

In some embodiments the one or more conductive layers is/are depositedon the top and the bottom surface of the flexible foil and on the topand the bottom surface of the one or more piezoelectric elements.

In some other embodiments the one or more conductive layers are twolayers, the first layer deposited on the top surface of the flexiblefoil and on the top of the one or more piezoelectric elements and thesecond layer deposited on the bottom surface of the flexible foil and onthe bottom surface of the one or more piezoelectric elements. Throughthe deposition of these conductive layers, the assembly is provided witha top electrode on the piezoelectric elements, which is connected to thetop metallization layer of the flexible foil and a bottom electrode onthe piezoelectric element which is connected to the bottom metallizationlayer of the flexible foil.

In some other embodiments the one or more conductive layers is one layerdeposited on the bottom surface of the flexible foil and on the bottomsurface of the one or more piezoelectric elements. This provides greatadvantages for protection of the electrical signal of the transducerfrom adverse external perturbations and is useful in the realization ofthe Faraday cage around the bottom electrode avoiding RF signalinterference with ultrasound signal during ablation.

In a second aspect of the invention an ultrasound transducer system ispresented that comprises: an ultrasound transducer assembly according tothe first aspect of the invention placed in a base structure; the basestructure comprising cavities, wherein the cavities are filled withbacking material; a coating layer deposited on the external surface ofthe ultrasound transducer assembly.

In some embodiments at least one of the cavities of the ultrasoundtransducer system extends from the top to the bottom surface of the basestructure. The cavities of the base structure may be considered asapertures in the base structure, providing access to the back side orback surface of the piezoelectric element placed on the base structure.The cavities in the base structure may communicate with each other, e.g.in presence of multiple piezoelectric elements or can be accessedindividually.

The ultrasound transducer assembly placed on the base structure may beglued on and around the base structure. When the ultrasound transducerassembly is placed on the base structure, the empty cavities located atthe backside, i.e. at the bottom surface, of the transducer elements arefilled with backing material. In this way the performance of thetransducer are only dependent on the piezoelectric and the backingmaterials, and are not influenced by the flexible foil. The flexiblefoil is not supporting the piezoelectric elements and the piezoelectricelements are embedded into it.

In placing the ultrasound transducer assembly onto the base structure,the openings of the flexible foil in which the piezoelectric elementsare fasten, e.g. by means of glue, are located in positionscorresponding to the cavities of the base structure. The back side orbottom surface of the piezoelectric elements is therefore accessiblethough the cavities of the base structure. The modality of addition ofthe backing material allows for freedom and good control of theappropriate choice of the material. For example, the filling materialcan be dispensed into the cavities by injection in a fluidic statethrough conducts in the base structure. Examples of filling materialscomprises adhesive which can rapidly bond to plastics and metal uponexposure to UV and/or visible light. Filling materials compositions mayalso comprise microspheres, such as ceramic or glass sphere, which canbe hollow, lightweight and with a high compressive strength.

In some other embodiments of the ultrasound transducer assemblyaccording to the first aspect of the invention, the fastening comprisesat least a side wall of one or more piezoelectric elements glued to theintemal rim of the openings. By gluing only the side or later wall ofthe piezoelectric elements the piezoelectric elements the acousticproperties of the piezoelectric system are not influenced by theflexible foil.

The invention is of great advantage in particular in the fabrication ofhigh frequency (HF) transducers. In traditional HF transducers, theflexible foil is included in the transducer stack and the transducerelements are place onto the flexible foil. As the higher the frequency,the lower the thickness of the piezoelectric elements, traditional HFtransducers have a high chance of failure due to high risk of breakdownas the electrodes from the front side and the backside of thepiezoelectric material are becoming too close with respect to eachother. The invention, by embedding the piezoelectric elements into theflexible foil, provides a solution which is therefore particularlyadvantageous for HF transducers.

In some embodiments the one or more piezoelectric elements is/are gluedwith non-conductive glue.

In some embodiments the one or more piezoelectric elements is/arefastened to the internal rim of the openings by an isolation layer, i.e.a layer having isolating properties.

In some other embodiments the ultrasound transducer assembly accordingto the first aspect of the invention further comprises an isolationlayer deposited onto the external surface of the ultrasound transducerassembly. This electrical isolation layer may be a matching layercoating the ultrasound transducer assembly for maximizing the acousticperformance of the transducer elements.

In a third aspect of the invention a catheter tip is presented thatcomprises an ultrasound transducer assembly according to the firstaspect of the invention.

In a fourth aspect of the invention a catheter tip is presented thatcomprises an ultrasound transducer system according to the second aspectof the invention.

The catheter tip may have irrigation holes through which the ultrasoundtransducer system communicates externally towards the environment, e.g.a pulmonary vein.

The catheter tip may also have other openings through which theultrasound transducers system can follow the ablation procedure oftissue unobstructed, e. g. for optical fibers. Alternatively, in case anultrasound transparent medium is used for ablation e.g.polymethylpentene coated with a thin platinum layer then the tip shouldnot necessarily contain openings.

When the ultrasound transducers are embedded in ablation catheters forenable real-time feedback on lesion front progression, the ablation capcan be mounted on the catheter body after the ultrasound transducerssystem is electrically connected and fixed in the catheter tip.

In a fifth aspect of the invention a method for fabricating anultrasound transducer assembly is presented that comprises: providing aflexible foil having openings extending from the top to the bottomsurface of the flexible foil; mounting one or more piezoelectricelements into the openings; depositing one or more conductive layers onthe flexible foil and the one or more piezoelectric elements.

In some embodiments according to the fifth aspect of the invention themounting comprises inserting the one or more piezoelectric elements intothe openings and gluing said one or more piezoelectric elements to theintemal rim of the openings.

In some embodiments according to the fifth aspect of the invention thedepositing comprises depositing one or more conductive layers on the topand bottom surface of the flexible foil and on the top and the bottomsurface of the one or more piezoelectric elements.

In a sixth aspect of the invention a method for fabricating anultrasound transducer system is presented that comprises: positioningthe ultrasound transducer assembly according to the first aspect of theinvention onto a base structure, the base structure comprising cavities;filling the cavities with backing material; depositing a coating layeron the external surface of the ultrasound transducer assembly.

In some embodiments according to this last aspect the positioningcomprises folding into a 3D structure the flexible foil containing theone or more piezoelectric elements and gluing the folded flexible foilaround the base structure.

In some embodiments according to this last aspect the filling comprisesdispensing backing material in a fluidic state and hardening the backingmaterial.

In general the various aspects of the invention may be combined andcoupled in any way possible within the scope of the invention. These andother aspects, features and/or advantages of the invention will beapparent from and elucidated with reference to the embodiments describedhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the invention will be described, by way of example only,with reference to the drawings.

FIG. 1 shows a perspective view of a flexible foil with patternedopenings according to embodiments of the invention.

FIG. 2 a shows a cross section of the flexible foil as shown in FIG. 1 .

FIG. 2 b shows a cross section of the flexible foil including apiezoelectric element according to embodiments of the invention.

FIG. 2 c shows a cross section of the flexible foil including apiezoelectric element glued into the opening of the flexible foilaccording to embodiments of the invention.

FIG. 3 a shows a cross section of the flexible foil as shown in FIG. 2 cwhere conducting electrodes are deposited.

FIG. 3 b shows a cross section of the flexible foil as shown in FIG. 3 apositioned on a base or supporting structure.

FIG. 3 c shows a cross section of the transducer assembly as shown inFIG. 3 b where the cavities in the base structure are filled withbacking material.

FIG. 4 a shows a cross section of the flexible foil as shown in FIG. 2 cwhere a single conducting electrode is deposited on the back surface ofthe flexible foil and piezoelectric element.

FIG. 4 b shows a cross section of the flexible foil as shown in FIG. 4 apositioned on a base or supporting structure.

FIG. 4 c shows a cross section of the transducer assembly as shown inFIG. 4 b where the cavities in the base structure are filled withbacking material.

FIG. 4 d shows a cross section of the transducer system as shown in FIG.4 c where a conducting electrode is deposited around the transducersystem.

FIG. 4 e shows a cross section of the transducer system as shown in FIG.4 d where a matching or electrical isolation layer is deposited aroundthe transducer system.

FIG. 5 shows a top view of a patterned flexible foil includingtransducer elements according to embodiments of the invention.

FIG. 6 shows a perspective view of a base element according toembodiments of the invention.

FIG. 7 shows an ultrasound transducer system according to embodiments ofthe invention.

FIG. 8 shows the flowchart of a method for fabricating an ultrasoundtransducer system according to one aspect of the invention.

FIG. 9 shows a prospective view of an ultrasound transducer systemaccording to embodiments of the invention comprising an ablation cap.

FIG. 10 shows a cross section view of an ultrasound transducer systemaccording to embodiments of the invention comprising an ablation cap.

DESCRIPTION OF EMBODIMENTS

FIG. 1 shows three steps of the method for fabricating an ultrasoundtransducer according to one aspect of the invention. On the flexiblefoil 1 a desired patterned is produced, e.g. opening 2, extending fromthe top surface 6 to a bottom surface 7. Piezoelectric elements, e.g.piezoelectric element 3, are located in into the openings, e.g. opening2 and fastened to the internal rim 8 of opening 2. Non-conductive glue 4may be used to fasten the piezoelectric element 3 to the intemal rim 8of opening 2.

FIG. 2 a shows a cross section of the flexible foil 1 before includingthe piezoelectric elements. The opening 2 is filled, as shown in FIG. 2b by a piezoelectric element 3. The mounting of the piezoelectricelement 3, e.g. a piezoelectric patch, is achieved by gluing the patchesin the designated areas at the rim or edge of the opening 2. In someembodiments the mounting of the piezoelectric element 3 may be achievedby gluing a thin peripheral annular region of the piezoelectric patch 3on the flexible foil 1.

FIG. 2 b shows the flexible foil 1 with opening 2 where thepiezoelectric element 3 is located into the opening 2.

FIG. 2 c shows the transducer assembly of FIG. 2 b where thepiezoelectric element 3, i.e. the external edge of the piezoelectricelement 3, is fastened to the inside edge, i.e. the intemal rim of theopening 2 of the flexible foil 1 by means of glue 4. The glue may benon-conductive glue so as to provide isolation of the piezoelectricelement 3, e.g. piezoelectric patch from the flexible foil 1.

FIG. 3 a shows the transducer assembly of FIG. 2 c after conductivelayers 5 are deposited on the flexible foil 1 and on the piezoelectricelement 2. In particular conductive layer 5a is deposited on the topsurface of the flexible foil 1 and of the piezoelectric element 2providing the top electrode, while the conductive layer 5b is depositedon the bottom surface of the flexible foil 1 and of the piezoelectricelement 2 providing the bottom electrode.

In FIG. 3 b the transducer assembly of FIG. 3 a is then placed onto abase structure 6, characterized by cavities 11 extending from the topsurface 12 to the bottom surface 13 of the base structure 6. Thetransducer assembly is filled with backing material 7 as shown in FIG. 3c .

In some other embodiments one layer is deposited on the bottom surfaceof the flexible foil and on the bottom surface of the one or morepiezoelectric element. FIG. 4 a shows a cross section of the flexiblefoil as shown in FIG. 2 c where a single conducting layer 17 isdeposited on the back surface of the flexible foil 1 and piezoelectricelement 3. The transducer assembly of FIG. 4 a is then placed onto abase structure 18, characterized by cavities 19 extending from the topsurface 20 to the bottom surface 21 of the base structure 18 as shown inFIG. 4 b .

The transducer assembly placed on the base structure 18 is filled withbacking material 22 as shown in FIG. 4 c .

In FIG. 4 d a coating layer 23 is deposited at least partially aroundthe transducer system as shown in FIG. 4 c . The transducer system asshown in FIG. 4 d can be further coated by a matching or electricalisolation layer 24 deposited around the transducer system.

The embodiment shown in FIG. 4 is an alternative to the embodimentsshown in FIG. 3 and provides great advantages for electrical signalisolation purposes.

FIG. 5 shows a top view of a patterned flexible foil includingtransducer elements according to an embodiment of the invention. Theflexible foil 28 is patterned so as to have a cross-shape having fiveopenings 10 in which piezoelectric elements 16 are going to beintroduced. Shape and number of openings depend on the base structure tobe used and on the number of piezoelectric elements to be fasten. Thisis within the knowledge of the person skilled in the art. The flexiblefoil 28 is designed so as to be folded in a three-dimensional structurewith matches, e.g. in one embodiment the shape of the base structure 9having cavities 14 as shown in FIG. 6 . By folding and gluing theultrasound transducer assembly onto the base structure the ultrasoundtransducer system 15 is produced as shown in FIG. 7 . The piezoelectricelements 16 fastened into the openings 10 of the flexible foil 28 arepositioned so as to face the cavities 14 of the base structure 9. Thecavities 14 are then filled with backing materials. The filling may beachieved through injection of backing material in fluidic state followedby hardening. Hardening may be achieved e.g. by curing in air, throughexposure to high temperature, exposure to UV light or through the use ofchemicals, such as chemical catalyst. In case of hardening with UVexposure, the base structure 9 is made of UV transparent material.

A further coating layer is deposited on the external surface of theultrasound transducer assembly 15 so as to provide electrical isolationfrom external disturbance, e.g. RF ablation.

In cardiac ablation monitoring, the ultrasound transducer system can beconnected and fixed in a catheter tip of a catheter allowing for forwardand sideward monitoring during ablation. After the ultrasound transducersystem is electrically connected and fixed in the catheter tip, theablation cap, e.g. a platinum ablation cap 25 as shown in FIGS. 9 and 10, can be mounted on the catheter body. The ablation tip may haveapertures though which the ultrasound transducer system can follow theablation procedure. Alternatively a material, such as polymethylpentenecoated with thin platinum layer, which is transparent to ultrasound maybe used. This avoids the need of apertures in the ablation tip.

FIG. 8 shows the flowchart of a method for fabricating an ultrasoundtransducer system according to one aspect of the invention.

In step (S1) 101, a flexible foil having openings extending from the topto the bottom surface is provided. The flexible foil may havemetallization, e.g. copper) on front and backsides or alternatively haspatterned metallization tracks on one of the sides for the front andbackside of the piezoelectric material, e.g. PZT.

In step (S2) 102, one or more piezoelectric elements is/are mounted intothe flexible foil openings. Mounting comprises inserting the one or morepiezoelectric elements into the openings of the flexible foil andfastening, e.g. by gluing the one or more piezoelectric elements to theinternal rim of the openings of the flexible foil.

In step (S3) 103, one or more conductive layers is/are deposited on theflexible foil and on the one or more piezoelectric elements. Depositingcomprises depositing one or more conductive layers on the top and/orbottom surface of the flexible foil and on the top and/or the bottomsurface of the one or more piezoelectric elements.

In step (S4) 104, the ultrasound transducer assembly produced in thefirst three steps is positioned onto a base structure which comprisescavities. Positioning the ultrasound transducer assembly on the basestructure comprises folding into a 3D structure the flexible foilcontaining the one or more piezoelectric elements and gluing the foldedflexible foil around the base structure.

In step (S5) 105, the cavities of the base structure are filled withbacking material. The filling comprises dispensing backing material in afluidic state and hardening the backing material. In step (S6) 106, acoating layer is deposited on the external surface of the ultrasoundtransducer assembly.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, such illustration and descriptionare to be considered illustrative or exemplary and not restrictive; theinvention is not limited to the disclosed embodiments. Other variationsto the disclosed embodiments can be understood and effected by thoseskilled in the art in practicing the claimed invention, from a study ofthe drawings, the disclosure, and the appended claims. In the claims,the word “comprising” does not exclude other elements or steps, and theindefinite article “a” or “an” does not exclude a plurality. A singleprocessor or other unit may fulfill the functions of several itemsrecited in the claims. The mere fact that certain measures are recitedin mutually different dependent claims does not indicate that acombination of these measures cannot be used to advantage. A computerprogram may be stored/distributed on a suitable medium, such as anoptical storage medium or a solid-state medium supplied together with oras part of other hardware, but may also be distributed in other forms,such as via the Internet or other wired or wireless telecommunicationsystems. Any reference signs in the claims should not be construed aslimiting the scope.

1. An apparatus, comprising: a catheter configured for insertion withina body, wherein a tip of the catheter comprises: an ultrasoundtransducer assembly configured for ultrasound imaging and comprising: aflexible material comprising a cross shape and a plurality of openingsdistributed on the cross shape; and a plurality of ultrasound transducerelements positioned within the plurality of openings; and a basestructure, wherein the ultrasound transducer assembly is coupled to thebase structure.
 2. The apparatus of claim 1, wherein the flexiblematerial comprises a folded configuration around the base structure. 3.The apparatus of claim 2, wherein the folded configuration comprises athree-dimensional structure corresponding to a shape of the basestructure.
 4. The apparatus of claim 2, wherein the plurality ofultrasound transducer elements comprises a first ultrasound transducerelement and a plurality of second ultrasound transducer elements,wherein in the folded configuration: the first ultrasound transducerelement comprises a forward-facing orientation; and the plurality ofsecond ultrasound transducer elements comprises a side-facingorientation.
 5. The apparatus of claim 1, wherein the plurality ofopenings comprises a first opening and a plurality of second openings,wherein the cross shape comprises a center and a plurality of armsextending from the center, wherein the center comprises the firstopening and the plurality of arms comprise the plurality of secondopenings.
 6. The apparatus of claim 5, wherein the plurality ofultrasound transducer elements comprises: a first ultrasound transducerelement comprising a forward-facing orientation; and a plurality ofsecond ultrasound transducer elements comprising a sideward-facingorientation, wherein the first ultrasound transducer element ispositioned within the first opening and the plurality of secondultrasound transducer elements are positioned within plurality of secondopenings.
 7. The apparatus of claim 1, wherein the base structurecomprises a plurality of planar faces.
 8. The apparatus of claim 7,wherein the cross shape is positioned on the plurality of planar faces.9. The apparatus of claim 7, wherein the plurality of planar facescomprises: a first planar face comprising a forward-facing orientation;and a plurality of second planar faces comprising a sideward-facingorientation.
 10. The apparatus of claim 9, wherein the cross shapecomprises a center and a plurality of arms extending from the center,wherein the center is positioned on the first planar face and theplurality of arms are positioned on the plurality of second planarfaces.
 11. The apparatus of claim 1, wherein the base structurecomprises a plurality of cavities aligned with the plurality of openingsand the plurality of ultrasound transducer elements.
 12. The apparatusof claim 11, wherein the base structure comprises a plurality of planarfaces, wherein the plurality of cavities is positioned on the pluralityof planar faces.
 13. The apparatus of claim 11, further comprising abacking material positioned within the plurality of cavities.
 14. Theapparatus of claim 1, wherein the flexible material comprises anextension extending from the cross shape, wherein the base structurecomprises a recess, wherein the extension is positioned within therecess.
 15. The apparatus of claim 1, wherein the plurality of openingsextends from a top surface to a bottom surface of the flexible material.16. The apparatus of claim 1, wherein the flexible material comprisesmetallized Kapton.